Feasibility of Using the Livongo-Insulia Study App for Patients With Type 2 Diabetes [Pilot Study]

Type 2 Diabetes Treated With Insulin Clinical Trial

— LISA Pilot  

Official title:

Feasibility of Using the Insulia App in an Integrated Platform With Livongo for Patients With Type 2 Diabetes Treated With Basal Insulin [Pilot Study]

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03980236
• Other study ID #: CP04573.A
• Status: Terminated
• Phase: N/A
• Start date: May 6, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: February 2021
• Source: Livongo Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Livongo-Insulia Study App Pilot Study (LISA Pilot) is a 3-month, prospective, interventional study. The purpose of this pilot study is to evaluate the feasibility of using the Livongo-Insulia Study App for individuals with type 2 diabetes using basal insulin. This will be assessed by measuring the impact of the Livongo-Insulia Study App on glycemic control for these individuals.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: May 31, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years
• Lives in the U.S.
• Able to speak, read and write in English
• Diagnosed with type 2 diabetes
• Currently treated with long-acting basal insulin analog (Lantus, Levemir, Toujeo, Basaglar, Tresiba U-100) and taking 1 injection per day
• Takes a daily dose = 0.75 units/kg
• Estimated A1c = 8% (based on existing Livongo data)
• Has been enrolled in Livongo for at least 12 weeks
• Uses an iPhone compatible with Insulia's compatibility matrix (iPhone 5 or higher; iOS 8 or newer)
• Willing to complete study questionnaires
• Willing to complete at-home A1c kits
• Willing to check before breakfast blood glucose at least once per day

Exclusion Criteria:

• Diagnosis of type 1 diabetes
• Currently using a long-acting basal insulin analog that is not supported by Insulia
• Currently using rapid-acting, short-acting, or intermediate-acting or premixed insulins
• Currently pregnant or planning pregnancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Treated With Insulin

Intervention

Device:
• Livongo-Insulia Study App
Throughout the study, participants will be asked to use the LIvongo-Insulia Study App daily to receive their basal insulin dose recommendation. Participants will need to check their before breakfast blood glucose using their Livongo meter. Then, they will need to open the Livongo-Insulia Study App and accept the uploaded blood glucose(s) from the Livongo meter. Once the appropriate information is received, participants will receive an insulin dose recommendation and should confirm once the dose has been taken. Depending on their blood glucose, participants may also receive coaching messages and coaching support from the Livongo program.

Locations

Country	Name	City	State
United States	Livongo	Mountain View	California

Sponsors (3)

Lead Sponsor	Collaborator
Livongo Health	Evidation Health, Voluntis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1c	Change in A1c from baseline to 12 weeks	12 weeks